MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, BUTTON, 8 X 12 MM; SMOOTH FIXATION PIN

Model Number TIGHTROPE ABS, BUTTON, 8 X 12 MM

Device Problems Contamination (1120); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bacterial Infection (1735); Pain (1994); Drug Resistant Bacterial Infection (4553)

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 1/9/2023, it was reported by an arthrex employee via email that a patient was admitted due to a dislocation of the right acromioclavicular joint on (b)(6) 2022.On (b)(6) 2022 an internal fixature procedure took place.Two ar-1588rt tightrope rt were implanted during the procedure.Shortly after the procedure, patient complaint of pain in the right arm and after surgeon examined the wound, it was found with secretion.The sutures were removed, and a culture was sent out for bacterial infection and drug sensitivity test.The culture shows patient had a staphylococcus aureus infection and was treated with levofloxacin and gentamicin sulfate antibiotic via intravenous.On (b)(6)2022, patient reported pain relief and there was no obvious exudation from the wound.Patient underwent a revision surgery on (b)(6) 2022.During the procedure, it was noticed that the plate was loosen and a small number of inflammatory cells and purulent secretions were also found in the wound.After cleaning up the inflammatory cells and purulent secretions, the purulent white substances were found around the titanium plate with loop and the line junction, which was determined to be line junction rejection secretions.After removing the line junction and the titanium plate with loop, the purulent white secretions were cleaned up.Two 2.0mm wires, for another manufacturer, were used for oblique fixation of acromioclavicular joint.Case was completed and patient has not reported to be in any discomfort.Additional information received on 1/18/2023: patient injured shoulder on (b)(6) 2022.Original surgery took place on (b)(6) 2022, in which two ar-1588rt tightrope rt were implanted.On (b)(6) 2022, patient experienced pain and the surgeon removed the wound sutures to take the wound secretions for bacterial culture and drug sensitivity test.The results for the culture came back on (b)(6) 2022, which showed a staphylococcus aureus infection.At this time, patient was treated with iv antibiotic and wound dressing change.On (b)(6) 2022, while changing the wound dressing, patient expressed pain relief and showed no exudation from the wound.X-ray showed the button from an ar-1588rt and ar-1588tb to be loose and so revision surgery was performed on (b)(6) 2022 to remove them.Both ar-1588rt and ar-1588tb were removed and revision surgery was completed using products from another manufacturer.Both procedures were performed by the same surgery and at the same facility.

Manufacturer Narrative

The complaint is confirmed.Visual evaluation of the pictures and the event description of an alleged ar-1588tb attached to the complaint.Upon evaluation of an x-ray that was taken, it was noted that the tightrope had come loose.This is a knee tightrope and specific tightropes are sold for use in ac repair.Also, in the surgical technique guide it notes that tightropes used in ac repair need to be knotted on top of the button where devices used in the knee do not.No indication was made if the device was knotted on top of the button.The probable cause being incorrect used of the device or not putting the knot at the top pf the button.Refer to the complaint attached x-rays pictures.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Type of Device: SMOOTH FIXATION PIN
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16263901
• MDR Text Key: 308406281
• Report Number: 1220246-2023-06197
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019621
• UDI-Public: 00888867019621
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Device Catalogue Number: AR-1588TB
• Device Lot Number: 14951914
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2023
• Date Device Manufactured: 04/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other